Every biosimilar that leaves our Chennai facility is built on a quality system aligned to WHO-GMP, India Schedule M, ICH Q7–Q10 and 21 CFR Part 11 — from raw material intake through final batch release.
Quality at Regenix is a manufacturing decision, not a post-hoc check. Every batch of insulin, GLP-1 analogue and anticoagulant we ship traces back to a validated process, a qualified facility and a documented person — captured in ALCOA+ records and reviewable on demand by any regulator or partner who asks.
Four independent control points — each owned by a separate function and each capable of stopping a batch from shipping if something doesn't add up.
Every SOP, batch record and analytical method version-controlled, trained, and re-issued on a defined review cadence.
Equipment qualification (IQ/OQ/PQ), process performance qualification, continued process verification — all linked to a master validation plan.
Identity, purity, potency, sterility and endotoxin testing performed in-house by qualified analysts on calibrated, IQ/OQ-qualified instruments.
Deviations, OOS investigations and CAPAs feed a structured improvement loop — closed against the root cause, not just the symptom.
Every batch passes through six controlled stages — each gated, documented and reviewable. No batch leaves the facility without a signed QA release certificate.
Identity test, vendor qualification, CoA verification
Critical parameter monitoring, environmental sampling
Grade A/B cleanrooms, validated aseptic technique
Identity, purity, potency, sterility, endotoxin, particulates
Batch record review against MFR, deviation closure
CoA issue, cold-chain shipper qualification, traceability
Every certificate is current, audited and available to qualified partners on request. Site Master File and DMF/CTD summaries shared after a signed NDA.
Demonstrates compliance with WHO TRS 986 Annex 2 and TRS 961 Annex 9 — the global baseline for cold-chain biologics manufacturing.
Manufacturing licence under Drugs and Cosmetics Act, 1940 — separately authorised for each marketed product and dosage form.
Compliant with the revised Schedule M of the Drugs and Cosmetics Rules — India's harmonised GMP standard effective 2024.
Quality management system certification — process approach, risk-based thinking, continual improvement across the organisation.
Aligned to Q7 (GMP for APIs), Q8 (Pharmaceutical Development), Q9 (Quality Risk Management) and Q10 (Pharmaceutical Quality System).
Electronic records and signatures validated to 21 CFR Part 11 and EU GMP Annex 11 — supporting ALCOA+ data integrity throughout the quality system.
Partners, regulators and qualified buyers can request a Site Master File summary, audit checklist response, or schedule a facility audit. Reach out to our Quality Assurance team.